NCT02283684

GreenLight Laser Photoselective Vaporization of the Prostate vs Bipolar Transurethral Vaporization of the Prostate; RCT

Green Light Laser (XPS) Photoselective Vaporization of the Prostate (PVP) Versus Bipolar Transurethral Vaporization (B.TUVP) of the Prostate for Treatment of Small to Moderate Sized Benign Prostate Hyperplasia: A Randomized Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Mansoura University · Academic / Other
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

With a growing body of knowledge on the promising advancements and recent clinical data of the third generations of the Greenlight PVP/XPS, it seems to be a real contender in the world of MIS. Contenders of Greenlight laser technology includes bipolar as well as Holmium laser technology. In this study the investigators planned to test the Greenlight (532-nm) laser PVP using (XPS) 180W system compared to bipolar electro-vaporization, in reduction of LUTS secondary to small to moderate sized BPH in a prospective randomized trial.

Detailed description

Patients with LUTS due to BPH seen through the outpatient prostate clinic in the Mansoura UNC were assessed to evaluate if the patient is eligible to the study inclusion criteria. Patients who are meeting these criteria were asked to participate in this randomized comparative study and were provided with an informed consent form. Study participants were enrolled and randomized, and the appropriate scheduled procedures were performed. Preoperatively, all patients were thoroughly evaluated by medical history and physical exam, digital rectal exam (DRE), prostate specific antigen (PSA), urinalysis and urine culture, international index of prostate symptom score (IPSS), Quality of Life (QOL), transrectal ultrasound (TRUS) measurement of prostatic volume and biopsy whenever indicated, measurement of post-void residual assessment (PVR), and maximum urinary flow rate (Qmax). Preoperative flexible urethrocystoscopy was done when hematuria was the presenting symptom.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
PROCEDURE	Greenlight laser PVP	Vaporization of the prostate adenoma using 532nm laser with 180W XPS system using Moxy fiber
PROCEDURE	Bipolar TUVP	Bipolar energy is used for generation of plasma that ends up by vaporization of the prostate adenoma

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-11-01
• Completion: 2018-02-01
• First posted: 2014-11-05
• Last updated: 2019-06-12

Locations

1 site across 1 country: Egypt